Overview
November 2025 marks one of the most significant milestones in the transformation of Brazilian Foreign Trade: ANVISA’s phased adherence to the New Import Process (NPI), highlighting the migration of critical categories, such as medicines for human use and pharmaceutical inputs. This article details the implications of this change for the regulated sector, analyzing how the Single Import Declaration (DUIMP) and the digitalization of processes impact the supply chain and elevate the level of industry compliance.
Introduction
The Journey of Foreign Trade Modernization
The New Import Process (NPI) is part of the Federal Government’s ambitious project to modernize, simplify, and de-bureaucratize foreign trade, centralizing information in the Siscomex Single Portal. For the National Health Regulatory Agency (ANVISA), integration into the NPI is occurring in phases, ensuring a safe and controlled transition for products under sanitary surveillance.
Following the migration of food, cosmetics, and sanitizing products in previous months, November 2025 is drawing the attention of the healthcare industry. The adherence of high-value and critical regulatory categories, such as Medicines for Human Use and Pharmaceutical Inputs, is a watershed moment that demands full attention and adaptation from GRP Brazil companies.
The Impacts of DUIMP on Medicines and Inputs
Starting on November 3, 2025 (according to ANVISA’s migration schedule), import consent for essential categories, such as medicines and controlled substances (Ordinance SVS/MS 344/1998), began to be carried out, primarily, through the Single Import Declaration (DUIMP).
- Goodbye LI/DI, Hello DUIMP
The main change is the replacement of the old flow of Import License (LI) and Import Declaration (DI) with a single declaration (DUIMP).
The Gain: Centralization promises greater agility and predictability in the process. ANVISA’s analysis, which was previously done on the LI, is now integrated with the DUIMP analysis, allowing the sharing of data and documents between different consenting bodies (ANVISA, Federal Revenue, VIGIAGRO, etc.).
The Challenge: Correct fiscal classification (NCM) and the accurate completion of Product Attributes in the DUIMP become crucial. Sanitary information must be precise from the start, as errors can stall the process and cause delays in customs clearance.
- Control of Controlled Substances (Ordinance 344/98)
The inclusion of medicines and substances subject to special control (Ordinance 344/98) in the NPI represents an advance in traceability and inspection.
The Focus: The new system allows for more robust and real-time control over the movement of these substances, ensuring that the imported quantities are in strict compliance with the Specific Authorizations (AE) and other sanitary requirements.
- The Arrival of Medical Devices
For the Health Products sector, the next relevant phase will occur on November 17, 2025, with the migration of Medical Devices (Health Products). This stage will complete the inclusion of the most critical categories of the health sector into the new platform.
Important Points for Compliance and Logistics
The transition to the NPI requires a deep review of the industry’s internal processes:
- Attribute Mastery: The company must master the completion of ANVISA’s Attributes in the DUIMP. These attributes are the specific information fields that replace the old LI language and are essential for consent.
- Single Entry Point: Migration forces the industry to adopt the Single Portal. Companies that still rely on manual or decentralized processes will face bottlenecks and delays.
- Supply Chain Impact: Agility in customs clearance, when compliance is up to date, reduces the time critical goods (such as inputs with limited shelf life) remain in ports and airports, decreasing storage costs and the risk of loss.
Conclusion
ANVISA’s phased adherence to the New Import Process in November 2025, with the inclusion of medicines and inputs, represents the consolidation of the modernization of Foreign Trade for Health Products.
For GRP Brazil, the message is one of immediate preparation and investment in technology. The NPI is not just a system change, but a demand for smarter and more integrated compliance. Those companies that invest in adapting their systems and training their trade and regulatory teams will reap the benefits of agility and predictability, ensuring the continuous and safe supply of products essential to public health.
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References
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.